{"answer":{"query":"Tyvaso Dpi","resolved_as":"applications","packages":18,"applications":["NDA214324"],"identity":{"application_numbers":["NDA214324"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"KIT","untrusted":true},{"text":"INHALANT","untrusted":true}],"marketing_start":{"earliest":"2022-05-23","latest":"2025-11-07","packages_with_a_start_date":18}},"generic_entry":[{"application":"NDA214324","date":"2042-02-03","reading":"upper bound from listed dates, not a forecast","basis":"latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled)","driver":{"kind":"patent","ref":"11826327","productNo":"001"},"latest_patent_expiry":"2042-02-03","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":35,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":7,"exclusivities_listed":0,"fact_id":"7ed51df2d59a9c104e7e063c"}],"label_history":{"events_total":1,"non_cmc_events":1,"counts_by_class":{"LABELING":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA214324","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-09-23","documents":[{"type":"Letter","date":"2026-09-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214324Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214324Orig1s007lbl.pdf","untrusted":true}}],"fact_id":"72432023ad8afa7076500f88"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":5,"te_code_counts":{"TBD":1,"NOT_PROVIDED":4},"marketing_status_counts":{"Prescription":5},"meaning":"raw FDA codes; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"NDA214324","product_no":"001","te_code":"TBD","marketing_status":"Prescription","drug_name":{"text":"TYVASO DPI","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"0.016MG/INH","untrusted":true}},{"application":"NDA214324","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TYVASO DPI","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"0.032MG/INH","untrusted":true}},{"application":"NDA214324","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TYVASO DPI","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"0.064MG/INH","untrusted":true}},{"application":"NDA214324","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TYVASO DPI","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"0.048MG/INH","untrusted":true}},{"application":"NDA214324","product_no":"005","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TYVASO DPI","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"0.08MG/INH","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Treprostinil","untrusted":true},"brand":{"text":"Tyvaso Dpi","untrusted":true}},"latest_year":2024,"series":[{"year":2022,"gross_spending_usd":78215742.66,"claims":3424,"beneficiaries":1141,"average_spending_per_claim_usd":22843.382786,"fact_id":"d6819f6a517831b591e52b86"},{"year":2023,"gross_spending_usd":436921533.43,"claims":18556,"beneficiaries":3017,"average_spending_per_claim_usd":23546.105488,"fact_id":"90fdcbd01d5fc2436711ded6"},{"year":2024,"gross_spending_usd":728752454.61,"claims":30325,"beneficiaries":4385,"average_spending_per_claim_usd":24031.408231,"fact_id":"d49aa9a24b6572ac21b44815"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; 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See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"AMBIGUOUS","field":"spending","reason":"2 brand and generic name pairs match; the series shown is the one with the newest year and the largest spending"},{"code":"NO_DATA","field":"biologic_status","reason":"no biologic application of this drug has a Purple Book status in the edition (a drug that is not a biologic has none)"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}